The speech of Ethical, the provider of eAdjudication®, the Cloud Software Solution that makes Clinical Endpoint Adjudication Management effective and quality compliant.

Juan Torres, from Sintax For Science, Statistical Expert and Ethical's partner, and Mimmo Garibbo, Ethical Director, introduces the "Effects of Central Adjudication in Bias, Variability, Sample Size and Study Power" based on a study that Ethical is supporting and that will be probably published by the end of the year.

During the speech the Statistical Theoretical Background about Bias , Variability and their effects on Clinical Trials Sample Size were introduced to reach the conclusion that "the use of centralized readings may reduce error in endpoint assessment and therefore be used as a tool to reduce sample size or increase power"

The aim of our work is to assess the effects that central reading might have on bias, variability, sample size and power to detect actual differences between treatments. Effects of central reading will be assessed and discussed depending on the type of endpoint: surrogate markers of disease (typically laboratory derived, quantitative, and easily standardized), imaging or histological endpoints (measurements of accuracy requiring standardization), and clinician-dependent (and subject-dependent) assessments (based on validated scales and considered subjective). (Krumholz-Bahner et al. 2015)

INTRODUCTION

Independent Review Committees (IRCs) review accumulating data in a clinical trial and advise the sponsor (directly or indirectly) on the future management of the trial.

Endpoint adjudication is an important task that might be conducted by a IRCs. Endpoint adjudication is growing as a tool in drug development (Krumholz-Bahner et al. 2015).

A survey gathered information about 140 organizations showed that 69% of the NMEs approved in the US used an adjudication method in their phase III development program whereas, in Europe, 41% of the approvals included a central review (Ethical GmbH 2015).

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About Juan V. Torres:
Juan is a biostatistician with more than 10 years of experience in drug development. His specialty is in combining a vigorous knowledge of theoretical statistics with advanced skills in SAS and R programming. Juan is founder member of the Catalonian Statistical Society, and active member of the Spanish Biometric Society, and the International Society of Clinical Biostatistics (ISCB). He is also member of the Statistics in Regulatory Affairs Sub-Committee of the ISCB Society, and vice-president of the Balearic Biotechnological and Biomedical cluster. Juan is a partner of Ethical where he plays the role of Expert Statistician.

About Mimmo Garibbo
Director of Ethical GmbH. Mimmo has been working in eClinical Systems & Data Management services since 1999. In 2013 founded in Basel (Switzerland) Ethical GmbH, mainly focused on Endpoint Adjudication Management Software.

During years contributed to hundred of Clinical Trials with the design & management of CTMS, EDC, Safety Databases, Patients' Registries and Endpoint Adjudication solutions in partnership with Pharma Companies, AROs or CROs.
Mimmo is the Founder of the Endpoint Adjudication Professional Group on Linkedin

eAdjudication®Solution Description

About Ethical

Ethical GmbH is an eClinical Company focused on Endpoint
Adjudication. Our
approach is based upon our staff’s experience providing software solutions to support some 300
international
clinical trials with more than 10,000 investigator sites and hundreds of thousands of patients.
Our solution
was shaped by the insight that AROs, CROs, and clinical trial sponsors need an Endpoint
Adjudication
platform and software solution that is easier to implement and for their study teams, data
reviewers and
adjudication committees to use. The result — a combination of out-of-the-box, effective Endpoint
Adjudication software features with complete technical infrastructure management that employs a
cloud
software-as-a-service provisioning model.